Potential Defect Prompts Mylan EpiPen Recall
NEW YORK (CBSNewYork) — Meridian Medical Technologies, makers of Mylan's EpiPen Auto-Injector, have issued a voluntary recall of its EpiPen and EpiPen Jr. injectors.
"The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis)," the company said in a statement on its website.
The recall affects 13 kinds of EpiPen and EpiPen Jr. devices that were distributed between December 17, 2015 and July 1, 2016.
| Product/Dosage | NDC Number | Lot Number | Expiration Date |
|---|---|---|---|
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 5GN767 | April 2017 |
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 5GN773 | April 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 5GM631 | April 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 5GM640 | May 2017 |
| EpiPen Jr Auto-Injector, 0.15 mg | 49502-501-02 | 6GN215 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM082 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM072 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM081 | September 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM088 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM199 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM091 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM198 | October 2017 |
| EpiPen Auto-Injector, 0.3 mg | 49502-500-02 | 6GM087 | October 2017 |
Mylan advised consumers to use their current EpiPens, if needed, until they receive a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.
Anyone with any adverse reactions or device malfunctions can report them to the Food and Drug Administration's MedWatch program by clicking here.
